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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Scarring (2061); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced bowel obstruction, bowel perforation, severe pain, nausea, vomiting, and scarring.Treatment included partial surgical removal of the mesh seven years after implant.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced significant pain, nausea, infection, inflammation, infection, drainage, hospitalization, and scarring.Treatment included partial surgical removal of pieces of the infected mesh two months after implant and wound debridement.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced significant pain, nausea, infection, inflammation, recurrence, drainage, scarring, infection, scar tissue, significant amount of purulent material, large portion of mesh not incorporated, wound packed, vomiting, abdominal pain, adhesions, small bowel obstruction, and draining sinus tract.Post-operative patient treatment included partial surgical removal of pieces of the infected mesh, debridement of draining sinus tract, and wound debridement.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced significant pain, nausea, infection, inflammation, recurrence, drainage, scarring, infection, scar tissue, significant amount of purulent material, large portion of mesh not incorporated, wound packed, vomiting, abdominal pain, adhesions, small bowel obstruction, and draining sinus tract.Post-operative patient treatment included partial surgical removal of pieces of the infected mesh, debridement of draining sinus tract, patient admitted to the hospital for abdominal pain, and wound debridement.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.Additional information: b2(change other to intervention required), b5, d7, g4, h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced significant pain, nausea, infection, inflammation, recurrence, drainage, hospitalization, and scarring.Post-operative patient treatment included partial surgical removal of pieces of the infected mesh and wound debridement.
 
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Brand Name
MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key7879726
MDR Text Key120379979
Report Number9615742-2018-02096
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2013
Device Model NumberPCO2015
Device Catalogue NumberPCO2015
Device Lot NumberPIK00077
Was Device Available for Evaluation? No
Date Manufacturer Received02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Weight91
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